公开(公告)号：US06316018B1

公开(公告)日：2001-11-13

申请号：US09491152

申请日：2000-01-26

Applicant: Ni Ding ,  Jennifer E. Raeder-Devens ,  Tuyethoa Thi Trinh

Inventor： Ni Ding ,  Jennifer E. Raeder-Devens ,  Tuyethoa Thi Trinh

IPC: A61F202

CPC classification number: A61L27/50 ,  A61L27/34 ,  A61L29/085 ,  A61L29/16 ,  A61L31/10 ,  A61L31/16 ,  A61L2300/236 ,  A61L2300/258 ,  A61L2300/41 ,  A61L2300/414 ,  A61L2300/42 ,  A61L2300/602 ,  A61L2300/606 ,  A61L2300/608 ,  A61L2300/61 ,  A61L2300/802

Abstract: The invention is directed to medical devices having a drug-releasing coating and methods for making such coated devices. The coating permits timed or prolonged pharmacological activity on the surface of medical devices through a reservoir concept. Specifically, the coating comprises at least two layers: an outer layer containing at least one drug-ionic surfactant complex overlying a reservoir layer containing a polymer and the drug which is substantially free of an ionic surfactant. Upon exposure to body tissue of a medical device covered with such coating, the ionically bound drug in the outer layer is released into body fluid or tissue. Following release of such bound drug, the ionic surfactant binding sites in the outer layer are left vacant. To maintain the pharmacological activity after delivery of the ionically bound drug, additional amounts of the drug are embedded or incorporated in the reservoir layer in a manner which allows the drug, which is substantially free of ionic surfactants, to complex with the vacant binding sites of the ionic surfactant of the outer layer. As a result, the surface of the medical device is enriched with the drug to provide sustained pharmacological activity to prevent the adverse reaction due to the presence of the medical device. The invention is further directed to medical devices with stabilized drug-releasing coatings. The coatings are stabilized by exposure to a low energy, relatively non-penetrating energy source, e.g., gas plasma or an electron beam energy source.

Abstract translation: 本发明涉及具有药物释放涂层的医疗装置及其制造方法。 涂层允许通过储存器概念在医疗装置的表面上定时或延长药理活性。 具体地说，该涂层包括至少两层：包含至少一种药物 - 离子表面活性剂复合物的外层，其中包含聚合物的储存层和基本上不含离子表面活性剂的药物。 在暴露于用这种涂层覆盖的医疗装置的身体组织上时，外层中的离子结合药物被释放到体液或组织中。 释放这种结合药物后，外层中的离子表面活性剂结合位点留空。 为了在输送离子结合的药物之后保持药理活性，将额外量的药物以允许基本上不含离子表面活性剂的药物与储存层中的空位结合位点复合的方式嵌入或并入储存层中 外层的离子表面活性剂。 结果，医疗装置的表面富含药物以提供持续的药理活性，以防止由于存在医疗装置而引起的不良反应。 本发明进一步涉及具有稳定的药物释放涂层的医疗装置。 通过暴露于低能量，相对非穿透能量源（例如气体等离子体或电子束能量源）来使涂层稳定。

公开(公告)号：US06265016B1

公开(公告)日：2001-07-24

申请号：US09531925

申请日：2000-03-21

Applicant: Fritz Hostettler ,  David Rhum ,  Michael R. Forman ,  Michael N. Helmus ,  Ni Ding

Inventor： Fritz Hostettler ,  David Rhum ,  Michael R. Forman ,  Michael N. Helmus ,  Ni Ding

IPC: B05D302

CPC classification number: C08J7/047 ,  A61L29/085 ,  A61L31/10 ,  C08G18/10 ,  C08G18/283 ,  C08G2230/00 ,  C08J7/04 ,  C08J2475/00 ,  Y10T428/31554 ,  Y10T428/31562 ,  Y10T428/31565 ,  Y10T428/31569 ,  Y10T428/31587 ,  Y10T428/31678 ,  A61L31/145 ,  A61L29/145 ,  C08L75/04 ,  C08G18/307 ,  C08G18/3225

Abstract: A process for the preparation of slippery, hydrophilic polyurethane hydrogel coating compositions, and materials composed of a polymeric plastic or rubber substrate or a metal substrate with a coating of a slippery, hydrophilic polyurethane hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device. The hydrogel coating compositions are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water.

Abstract translation: 用于制备光滑的亲水性聚氨酯水凝胶涂料组合物的方法，以及由聚合物塑料或橡胶基材或金属基材组成的材料，其上具有光滑的亲水性聚氨酯水凝胶涂层，使得涂料组合物顽固地粘附于基材 ，被披露。 涂料组合物和涂层材料是无毒的和生物相容的，并且理想地适用于医疗装置，特别是导管，导管气囊和支架。 涂层组合物，涂覆材料和涂覆的装置表现出与体液，特别是血液接触的低摩擦系数，以及在长时间使用该装置时高度的磨损持久性。 水凝胶涂料组合物能够被干燥以促进其已被施加到其上的装置的储存，并且可以立即重新活化以便随后通过暴露于水中使用。

公开(公告)号：US6120536A

公开(公告)日：2000-09-19

申请号：US663518

申请日：1996-06-13

Applicant: Ni Ding ,  Michael N. Helmus

Inventor： Ni Ding ,  Michael N. Helmus

IPC: A61F2/00 ,  A61F2/82 ,  A61F2/86 ,  A61F2/90 ,  A61L27/00 ,  A61L27/22 ,  A61L31/08 ,  A61L31/10 ,  A61L31/14 ,  A61L31/16 ,  A61L33/00 ,  A61L33/10 ,  A61F2/06

CPC classification number: A61L33/0011 ,  A61L27/227 ,  A61L31/08 ,  A61L31/10 ,  A61L31/16 ,  A61F2210/0014 ,  A61F2250/0067 ,  A61L2300/236 ,  A61L2300/42 ,  A61L2300/602 ,  A61L2300/606 ,  A61L2300/622

Abstract: A coating and method for implantable open lattice metallic stent prostheses are disclosed. The coating includes a relatively thin layer of biostable elastomeric material containing an amount of biologically active material, particularly heparin, dispersed in the coating in combination with a non-thrombogenic surface. In one embodiment, the surface is provided with sites of high electronegativity species by coating with fluorosilicone which aid in controlling elution, particularly the initial release rate, and reduced thrombogenic activity. Other non-thrombogenic outer layers for heparin such as covalently bound polyethylene glycol (PEG) are also disclosed.

Abstract translation: 公开了一种用于可植入的开放格子金属支架假体的涂层和方法。 涂层包括相对薄的生物稳定的弹性材料层，其中含有一定数量的生物活性材料，特别是肝素，其与非血栓形成的表面组合分散在涂层中。 在一个实施方案中，通过用有助于控制洗脱，特别是初始释放速率和有助于降低血栓形成活性的氟硅氧烷来涂覆高电负性物质的表面。 还公开了用于肝素的其它非血栓形成外层，例如共价结合的聚乙二醇（PEG）。

公开(公告)号：US6030656A

公开(公告)日：2000-02-29

申请号：US126375

申请日：1998-03-24

Applicant: Fritz Hostettler ,  David Rhum ,  Michael R. Forman ,  Michael N. Helmus ,  Ni Ding

Inventor： Fritz Hostettler ,  David Rhum ,  Michael R. Forman ,  Michael N. Helmus ,  Ni Ding

IPC: A61L29/08 ,  A61L31/10 ,  C08G18/10 ,  C08G18/28 ,  C08J7/04 ,  B05D7/14

CPC classification number: C08J7/047 ,  A61L29/085 ,  A61L31/10 ,  C08G18/10 ,  C08G18/283 ,  C08J7/04 ,  C08G2230/00 ,  C08J2475/00 ,  Y10T428/31554 ,  Y10T428/31562 ,  Y10T428/31565 ,  Y10T428/31569 ,  Y10T428/31587 ,  Y10T428/31678

Abstract: A process for the preparation of slippery, hydrophilic polyurethane hydrogel coating compositions, and materials composed of a polymeric plastic or rubber substrate or a metal substrate with a coating of a slippery, hydrophilic polyurethane hydrogel thereon, such that the coating composition tenaciously adheres to the substrate, are disclosed. The coating compositions and coated materials are non-toxic and biocompatible, and are ideally suited for use on medical devices, particularly, catheters, catheter balloons and stents. The coating compositions, coated materials and coated devices demonstrate low coefficients of friction in contact with body fluids, especially blood, as well as a high degree of wear permanence over prolonged use of the device. The hydrogel coating compositions are capable of being dried to facilitate storage of the devices to which they have been applied, and can be instantly reactivated for later use by exposure to water.

Abstract translation: 用于制备光滑的亲水性聚氨酯水凝胶涂料组合物的方法，以及由聚合物塑料或橡胶基材或金属基材组成的材料，其上具有光滑的亲水性聚氨酯水凝胶涂层，使得涂料组合物顽固地粘附于基材 ，被披露。 涂料组合物和涂层材料是无毒的和生物相容的，并且理想地适用于医疗装置，特别是导管，导管气囊和支架。 涂层组合物，涂覆材料和涂覆的装置表现出与体液，特别是血液接触的低摩擦系数，以及在长时间使用该装置时高度的磨损持久性。 水凝胶涂料组合物能够被干燥以促进其已被施加到其上的装置的储存，并且可以立即重新活化以便随后通过暴露于水中使用。

公开(公告)号：US09675737B2

公开(公告)日：2017-06-13

申请号：US12851420

申请日：2010-08-05

Applicant: Ni Ding

Inventor： Ni Ding

IPC: A01N25/34 ,  A61F13/00 ,  B65D81/24 ,  A61L31/10

CPC classification number: A61L31/10 ,  Y10T428/1307

Abstract: A method of providing an antioxidant to a medical device and a kit are described.

公开(公告)号：US09580558B2

公开(公告)日：2017-02-28

申请号：US12135921

申请日：2008-06-09

Applicant: Ni Ding ,  Stephen D. Pacetti

Inventor： Ni Ding ,  Stephen D. Pacetti

IPC: C08G77/442 ,  C08L83/04 ,  A61L31/16 ,  A61L31/10

CPC classification number: C08G77/442 ,  A61L31/10 ,  A61L31/16 ,  A61L2300/00 ,  C08L83/04

Abstract: A polymer of siloxanes as flexibility monomers and strength monomers is provided. It is also provided a polymer blend that contains a polymer formed of siloxane monomers and strength monomers and another biocompatible polymer. The biocompatible polymer or polymer blend described herein and optionally a bioactive agent can form a coating on an implantable device such as a drug-delivery stent. The implantable device can be used for treating or preventing a disorder such as atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, or combinations thereof.

Abstract translation: 提供了作为柔性单体和强度单体的硅氧烷的聚合物。 还提供了一种聚合物共混物，其包含由硅氧烷单体和强度单体形成的聚合物和另一种生物相容性聚合物。 本文所述的生物相容性聚合物或聚合物共混物和任选的生物活性剂可以在可植入装置如药物递送支架上形成涂层。 可植入装置可用于治疗或预防动脉粥样硬化，血栓形成，再狭窄，出血，血管解剖或穿孔，血管动脉瘤，易损斑块，慢性完全闭塞，跛行，静脉和人造移植物的吻合增殖等障碍，胆管阻塞 ，输尿管阻塞，肿瘤阻塞或其组合。

公开(公告)号：US08383158B2

公开(公告)日：2013-02-26

申请号：US10414602

申请日：2003-04-15

Applicant: Eugene T. Michal ,  Evgenia Mandrusov ,  Charles D. Claude ,  Ni Ding ,  Murthy Simhambhatla ,  Syed Faiyez Ahmed Hossainy ,  Srinivasan Sridharan ,  Paul Consigny

Inventor： Eugene T. Michal ,  Evgenia Mandrusov ,  Charles D. Claude ,  Ni Ding ,  Murthy Simhambhatla ,  Syed Faiyez Ahmed Hossainy ,  Srinivasan Sridharan ,  Paul Consigny

IPC: A61K9/14

CPC classification number: A61N1/3625 ,  A61K9/0024 ,  A61K31/00 ,  A61K31/728 ,  A61K31/732 ,  A61K31/734 ,  A61K31/78 ,  A61K31/79 ,  A61K36/886 ,  A61K38/40 ,  A61K41/0042 ,  A61K45/06 ,  A61K47/02 ,  A61K47/34 ,  A61K47/60 ,  A61K47/62 ,  A61K49/0404 ,  A61L24/043 ,  A61L27/20 ,  A61L27/50 ,  A61L27/54 ,  A61L2430/20 ,  A61N1/36521 ,  A61K2300/00

Abstract: Methods, devices, kits and compositions to treat a myocardial infarction. In one embodiment, the method includes the prevention of remodeling of the infarct zone of the ventricle. In other embodiments, the method includes the introduction of structurally reinforcing agents. In other embodiments, agents are introduced into a ventricle to increase compliance of the ventricle. In an alternative embodiment, the prevention of remodeling includes the prevention of thinning of the ventricular infarct zone. In another embodiment, the prevention of remodeling and thinning of the infarct zone involves the cross-linking of collagen and prevention of collagen slipping. In other embodiments, the structurally reinforcing agent may be accompanied by other therapeutic agents. These agents may include, but are not, limited to pro-fibroblastic and angiogenic agents.

Abstract translation: 用于治疗心肌梗塞的方法，装置，试剂盒和组合物。 在一个实施例中，该方法包括防止脑室梗死区的重塑。 在其它实施方案中，该方法包括引入结构上增强剂。 在其它实施方案中，将药剂引入心室以增加心室的依从性。 在替代实施例中，预防重塑包括防止心室梗塞区变薄。 在另一个实施方案中，预防梗塞区的重塑和变薄包括胶原蛋白的交联和预防胶原蛋白滑脱。 在其它实施方案中，结构上增强剂可以伴随其它治疗剂。 这些试剂可以包括但不限于前成纤维细胞和血管生成剂。

公开(公告)号：US20110260358A1

公开(公告)日：2011-10-27

申请号：US13093755

申请日：2011-04-25

Applicant: Yungbing Wang ,  Xiao Ma ,  Fuh-Wei Tang ,  Ni Ding

Inventor： Yungbing Wang ,  Xiao Ma ,  Fuh-Wei Tang ,  Ni Ding

IPC: B29C71/00

CPC classification number: B29C71/02 ,  A61F2/82 ,  A61F2/915 ,  A61F2002/91558 ,  A61F2002/91583 ,  A61F2210/0004 ,  A61F2240/001 ,  A61L2/007 ,  A61L2/08 ,  A61L2/087 ,  A61L31/06 ,  A61L31/148 ,  A61L2202/21 ,  A61L2202/24 ,  A61L2400/18 ,  B29C35/02 ,  B29C2035/0877 ,  B29C2071/022 ,  B29L2031/753 ,  C08J7/08 ,  C08J7/123 ,  C08J2367/04 ,  C08L67/04

Abstract: Methods are disclosed for conditioning a polymeric stent after sterilization, and/or after crimping and before packaging, such that the properties of the polymeric stent fall within a narrower range of values. The stent is exposed to a controlled temperature at or above ambient for a period of time after radiation sterilization and/or after crimping and before sterilization. As a result, the polymeric stent properties, particularly radial strength and number-average molecular weight of the polymer of the polymeric stent, fall within a narrower range.

Abstract translation: 公开了用于在灭菌后和/或在卷曲之后和包装之前调节聚合物支架的方法，使得聚合物支架的性质落在较窄的值范围内。 在辐射灭菌后和/或在压接之后和灭菌之前将支架暴露于等于或高于环境的受控温度一段时间。 结果，聚合物支架的聚合物支架性质，特别是聚合物支架的聚合物的径向强度和数均分子量落在更窄的范围内。

公开(公告)号：US20110212139A1

公开(公告)日：2011-09-01

申请号：US13102791

申请日：2011-05-06

Applicant: Ni Ding

Inventor： Ni Ding

IPC: A61F2/82 ,  A61K38/17 ,  A61P9/10 ,  A61P7/02

CPC classification number: A61L31/16 ,  A61F2/82 ,  A61K38/1709 ,  A61L31/10 ,  A61L2300/252 ,  A61L2300/416

Abstract: Method are disclosed for local and systemic administration HDL, recombinant HDL or HDLm for the prevention, treatment, or amelioration of a vascular disorder, disease or occlusion such as restenosis or vulnerable plaque.

Abstract translation: 公开了局部和全身给药HDL，重组HDL或HDLm用于预防，治疗或改善血管疾病，疾病或闭塞如再狭窄或易损斑块的方法。

公开(公告)号：US07923509B2

公开(公告)日：2011-04-12

申请号：US12578362

申请日：2009-10-13

Applicant: Leonard Pinchuk ,  Sepideh Hashemi ,  Marlene C. Schwarz ,  Kalpana Kamath ,  Ni Ding

Inventor： Leonard Pinchuk ,  Sepideh Hashemi ,  Marlene C. Schwarz ,  Kalpana Kamath ,  Ni Ding

IPC: C08L53/00 ,  C08L23/00 ,  C08L25/02 ,  C08F8/00

CPC classification number: C08L53/00 ,  A61L27/16 ,  A61L27/54 ,  A61L31/048 ,  A61L31/10 ,  A61L31/16 ,  A61L2300/416 ,  A61L2300/602 ,  A61L2300/606 ,  C08F293/005 ,  C08F297/00 ,  C08F297/04 ,  C08L53/02 ,  C09D153/00 ,  C09D153/02 ,  C08L2666/02

Abstract: A composition for delivery of a therapeutic agent is provided. The composition comprises: (a) a biocompatible block copolymer comprising one or more elastomeric blocks and one or more thermoplastic blocks and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent. The block copolymer is preferably of the formula X-(AB)n, where A is an elastomeric block, B is a thermoplastic block, n is a positive whole number and X is a seed molecule. The elastomeric blocks are preferably polyolefin blocks, and the thermoplastic blocks are preferably selected from vinyl aromatic blocks and methacrylate blocks. According to another aspect of the invention, a medical device is provided, at least a portion of which is insertable or implantable into the body of a patient. The medical device comprises (a) the above biocompatible block copolymer and (b) a therapeutic agent, wherein the block copolymer is loaded with the therapeutic agent. According to another aspect of the present invention, a method of treatment is provided in which the above device is implanted or inserted into a patient, resulting in the release of therapeutic agent in the patient over an extended period. According to yet another aspect of the invention, a coated medical device is provided which comprises: (a) an intravascular or intervascular medical device and (b) a coating over at least a portion of the intravascular or intervascular a medical device, wherein the coating comprises the above biocompatible block copolymer.

Abstract translation: 提供了用于递送治疗剂的组合物。 所述组合物包含：（a）包含一种或多种弹性体嵌段和一种或多种热塑性嵌段的生物相容性嵌段共聚物和（b）治疗剂，其中所述嵌段共聚物负载有所述治疗剂。 嵌段共聚物优选为式X-（AB）n，其中A为弹性体嵌段，B为热塑性嵌段，n为正整数，X为种子分子。 弹性体嵌段优选为聚烯烃嵌段，并且热塑性嵌段优选选自乙烯基芳族嵌段和甲基丙烯酸酯嵌段。 根据本发明的另一方面，提供一种医疗装置，其至少一部分可插入或植入患者体内。 医疗装置包括（a）上述生物相容性嵌段共聚物和（b）治疗剂，其中嵌段共聚物负载有治疗剂。 根据本发明的另一方面，提供了一种治疗方法，其中将上述装置植入或插入患者体内，导致治疗剂在患者体内长时间释放。 根据本发明的另一方面，提供了一种涂覆的医疗装置，其包括：（a）血管内或血管内医疗装置和（b）在血管内或血管内至少一部分医疗装置上的涂层，其中所述涂层 包括上述生物相容性嵌段共聚物。